44:69:01:01. Definitions.
Terms defined in SDCL 34-12-1.1 have the same meaning in this article. In addition, terms used in this article mean:

(1) "Abuse," an
intentional act toward an individual indicating that one or more of the
following has occurred:

(a) A criminal
conviction against a person for mistreatment toward an individual; or

(b) In the absence of
a criminal conviction, substantial evidence that one or more of the following
has occurred resulting in harm, pain, fear, or mental anguish:

(i) Misappropriation
of a patient's or resident's property or funds;

(ii) An
attempt to commit a crime against a patient or resident;

(iii) Physical
harm or injury against a patient or resident; or

(iv) Using
profanity, making gestures, or engaging in other acts made to or directed at a
patient or resident;

(2) "Adequate
staff," a sufficient number of qualified personnel to perform the duties
required to meet the performance criteria established by this article;

(3) "Administrator,"
a person appointed by the owner or governing body of a birth center who is
responsible for managing the birth center and who maintains an office on the
premises of the birth center;

(4) "Birth
center," any health care facility licensed under this article at which a
woman is scheduled to give birth following a normal, uncomplicated pregnancy,
but does not include a hospital or the residence of the woman giving birth;

(5) "Certified nurse
midwife," a provider duly authorized under this chapter to practice the
nursing specialty of nurse midwifery as defined in SDCL 36-9A-1;

(6) "Client," a
woman who is scheduled to give birth at a birth center and the newborn of that
birth;

(7) "Client
advocates," agencies responsible for the protection and advocacy of
clients, including the department, the state ombudsman, the protection and
advocacy network, and the Medicaid fraud control unit;

(8) "Department,"
the South Dakota Department of Health;

(9) "Dietary
manager," a person who is a dietitian, a graduate of an accredited
dietetic technician or dietetic manager training program, a graduate of a
course that provides 120 or more hours of classroom instruction in food service
supervision, or a certified dietary manager recognized by the National Certifying
Board of Dietary Managers and who functions with consultation from a dietitian;

(10) "Dietitian,"
a person who is registered with the Commission on Dietetic Registration of the
American Dietetic Association and holds a current license to practice in South
Dakota pursuant to SDCL chapter 36-10B;

(11) "Distinct
part," an identifiable unit, such as an entire ward or contiguous wards,
wing, floor, or building, which is licensed at a specific level. The term
includes all beds and related facilities in the unit;

(12) "Emergency
care," professional health services immediately necessary to preserve life
or stabilize health due to the sudden, severe, and unforeseen onset of illness
or accidental bodily injury;

(13) "Exploitation,"
the wrongful taking or exercising of control over property of a person with
intent to defraud that person;

(14) "Facility,"
the place of business used to provide health care for clients;

(15) "Governing
body," an organized body of persons that is ultimately responsible
for the quality of care in a health care facility, credentialing of and
granting privileges to the medical staff, maintaining the financial viability
of the facility, and formulating institutional policy;

(16) "Healthcare
worker," any paid person working in a health-care setting;

(17) "Legend
drug," any drug that requires the label bearing the statement
"Caution: Federal law prohibits dispensing without prescription";

(18) "Neglect,"
harm to a person's health or welfare, without reasonable justification, caused
by the conduct of someone responsible for the person's health or welfare,
including but not limited to offensive behavior made to or directed at a
client, and the failure to provide timely, consistent, and safe services,
treatment, or care necessary to avoid physical harm, mental anguish, or mental
illness to the person;

(19) "Nurse," a
registered nurse or a licensed practical nurse who holds a current license to
practice in South Dakota pursuant to SDCL chapter 36-9;

(20) "Nurse aide,"
a person providing nursing or nursing-related services who is not a licensed
health care worker, or someone who volunteers to provide such services without
pay;

(21) "Nurse
practitioner," a provider duly authorized under this chapter to practice
the specialty of nurse practitioner as defined in SDCL 36-9A-1;

(27) "Practitioner
staff," an organized staff composed of practitioners that operates under
bylaws approved by the governing body and which is responsible for reviewing
the qualifications of practitioners applying for clinical privileges and for
the provision of medical care to clients in a birth center;

(28) "Qualified
personnel," persons with the specific education, license, and training to
provide the health service for which they are employed;

(29) "Regular
diet," a nutritionally adequate diet using food items and written recipes
that can be prepared and correctly served by a staff person;

(30) "Self-administration
of medications," the removal of the correct dosage from the pharmaceutical
container and self-injecting, -ingesting, or -applying the medication with no
assistance or with assistance from qualified personnel of the birth center for
the correct dosage or frequency;

(31) "Social
worker," a person who is licensed pursuant to SDCL chapter 36-26;

(32) "Therapeutic
diet," any diet other than a regular diet that is ordered by a physician
as part of the treatment for a disease or clinical condition to increase,
decrease, or to eliminate certain substances in the diet, and to alter food
consistency; and

(33) "Transfer or
discharge," the movement of a client to a bed outside the distinct part or
outside the birth center.

44:69:01:02. Name
of birth center. Each birth center shall be designated by a pertinent and
distinctive name that shall be used in applying for a license. The name may not
be changed without first notifying the department in writing. No birth center
may be given a name or advertise in a way that implies services rendered are in
excess of the classification for which it is licensed or which would indicate
an ownership other than actual.

44:69:01:03. Bed
capacity. The department shall establish the bed capacity
of each birth center pursuant to the physical plant and space provisions of
this article. Where indicated, additional regulations specific to birth centers
with three or more beds apply. The client census may not exceed the bed
capacity for which the birth center is licensed. A request by the birth center
for an adjustment in bed capacity because of change of purpose or construction
shall be approved by the department before any changes are made.

44:69:01:04. Restrictions
on acceptance of clients. A birth center shall accept clients in accordance
with the following restrictions:

(1) A client admitted to a
birth center shall be housed within the birth center covered by the license;

(2) A licensed birth center
may not accept or retain clients who require care in excess of the
classification for which it is licensed; and

(3) Personnel essential to
maintaining adequate staff may not leave a licensed birth center during their
tour of duty in the birth center to provide services to persons who are not
clients of the birth center with the exception of providing emergency care on
premises contiguous to the birth center's property.

44:69:01:05. Joint
occupancy. The use of a portion of a building for purposes other than that
covered by the license may be approved by the department only if it can be
shown that joint occupancy is not detrimental to the welfare of the clients.
The area shall be open to inspection by the department.

44:69:01:06. Reports.
Each licensed birth center shall submit to the department the pertinent data
necessary to comply with the requirements of SDCL chapter 34-12 and this article.

Each birth center shall report to the
department within 48 hours of the event any death on birth center property and
any allegation of abuse or neglect of any client by any person.

Each birth center shall also report to
the department as soon as possible any fire with structural damage or where
injury or death occurs; any partial or complete evacuation of the birth center
resulting from natural disaster; or any loss of utilities, such as electricity,
natural gas, telephone, emergency generator, fire alarm, sprinklers, and other
critical equipment necessary for operation of the birth center for more than 24
hours,

Each birth center shall notify the
department of any anticipated closure or discontinuance of service at least 30
days in advance of the effective date.

44:69:01:07. Plans
of correction. Within 15 days of the receipt of the statement of
deficiencies, each birth center shall submit to the department a written plan
of correction for citations of noncompliance with licensure requirements. The
plan of correction shall be signed, dated, and on forms provided by the
department. The department may reject the plan of correction if there is no
evidence the plan will cause the birth center to attain or maintain compliance
with SDCL chapter 34-12 and this article.

44:69:01:08. Modifications.
Modifications to the staffing requirements provided in § 44:69:03:02 may
be approved by the department for licensed birth centers which are physically
combined and jointly operated. The health and safety of the client in either
birth center may not be jeopardized.

Modifications specified by this
section may be requested by the birth center. If the department approves the
modifications, the approval shall be in writing. The approval letter shall
specify the modifications permitted and any limitations pertaining to the
modifications.

44:69:01:09. Scope
of article. Nothing in article 44:69 limits or expands the rights of any
healthcare worker to provide services within the scope of the professional's
license, certification, or registration, as provided by South Dakota law.

44:69:02:01. Sanitation.
The birth center shall be designed, constructed, maintained, and operated to
minimize the sources and transmission of infectious diseases to clients,
personnel, visitors, and the community at large.

Cross-Reference:
Physically disabled, blind or deaf person's right to be accompanied by guide
dog without extra charge, SDCL 20-13-23.2.

Rule 44:69:02:03 Cleaning methods and facilities.

44:69:02:03. Cleaning
methods and facilities. The birth center shall have equipment, work areas,
and complete written procedures for cleaning, sanitizing, disinfecting, or
sterilizing all work areas, equipment, utensils, dressings, medical devices,
and solutions used for clients' care. Common use equipment shall be disinfected
or sterilized after each use.

A separate clean and soiled utility
room shall be provided for birth centers with three or more beds.

All parts of the birth center shall be
kept clean, neat, and free of visible soil, litter, and rubbish.

44:69:02:04. Sterilization.
Instruments, supplies, utensils and equipment which are not single service
shall be decontaminated before sterilization in a manner that makes them safe
for handling by personnel. Supplies and equipment commercially prepared and
sterilized to retain sterility indefinitely are acceptable in lieu of
sterilization in the birth center. Autoclaves used for steam sterilization
shall be bacteriologically monitored at least weekly. Supplies and equipment
sterilized and packaged in the birth center shall have the processing date on
the package and shall be reprocessed in accordance with any specific
manufacturer's recommendation for the packaging.

44:69:02:05. Food
service. If an in-house food service is provided, the birth center shall
meet the safety and sanitation procedures for food service in
§§ 44:02:07:01, 44:02:07:02, and 44:02:07:04 to 44:02:07:95, inclusive, in
the Food Service Code. The birth center shall have the space, equipment,
supplies, and mechanical systems for efficient, safe, and sanitary food
preparation. If a birth center's food service is contracted out, the contractor
shall be a licensed food service establishment that is inspected by a local,
state, or federal agency.

Note:
Article 44:02, Lodging and Food Service, Administrative Rules of South Dakota,
contains the Food Service Code and may be obtained from Legislative Mail, 1320
East Sioux Avenue, Pierre, South Dakota 57501, telephone (605) 773-4935, for
$4.08.

Rule 44:69:02:06 Linen.

44:69:02:06. Linen.
The supply of bed linen and towels shall equal two times the licensed capacity.
Each birth center shall contract with commercial laundry services or the
laundry service of another licensed health care facility for all common use
linens if laundry services are not provided on the premises. A birth center
providing laundry services shall have adequate space and equipment for the safe
and effective operation of the laundry service.

44:69:02:07. Infection
control. The infection control program shall utilize the concept of
standard precautions as the basis for infection control pursuant to chapter
44:20:04. The birth center shall have written procedures that govern the use of
aseptic techniques and procedures in all areas of the birth center. Each birth
center shall develop policies and procedures for the handling and storage of
potentially hazardous substances (including lab specimens).

A birth center with three or more beds
shall designate an employee to be responsible for the implementation of the
infection control program including surveillance and reporting activities.

Each birth center shall provide an
organized infection control program for preventing, investigating, and controlling
infection.

44:69:02:08. Occupant
protection. Each birth center shall be constructed, arranged, equipped,
maintained, and operated to avoid injury or danger to any occupant. The extent
and complexity of occupant protection precautions is determined by the services
offered and the physical needs of any client admitted to the birth center.

A birth center with three or more beds
shall take at least the following precautions:

(1) Develop and implement a
written and scheduled preventive maintenance program;

(2) Provide securely
constructed and conveniently located grab bars in all toilet rooms and bathing
areas used by clients;

(3) Provide a call system
for each birth room and in all toilet rooms and bathing facilities routinely
used by clients. The call system shall be capable of being easily activated by
a client and shall register at a staff location. A wireless call system may be
used;

(4) Provide grounded or
double-insulated electrical equipment or protect the equipment with ground
fault circuit interrupters. Ground fault circuit interrupters shall be provided
in wet areas and for outlets within six feet of sinks;

(5) Portable space heaters
and portable halogen lamps may not be used in a birth center;

(6) Household-type electric
blankets or heating pads may not be used in a facility;

(7) Any light fixture
located over a client bed, in any bathing or treatment area, in a clean supply
storage room, in any laundry clean linen storage area, or in any medication
set-up area shall be equipped with a lens cover or a shatterproof lamp; and

(8) Any clothes dryer shall
have a galvanized metal vent pipe for exhaust.

44:06:02:09. Physical
plant changes. A birth center shall submit any proposed change by new
construction, remodeling, or change of use of an area to the department. Any
change shall have the approval of the department before it is made.

44:69:02:10. Location.
The location of a birth center shall promote the health, treatment, comfort,
safety, and well-being of persons accepted and retained for care. A birth
center shall be served by good, passable roads. Easy accessibility for
employees, visitors, and fire-fighting services shall be maintained.

44:69:02:11. Other
hazardous conditions. A birth center may be directed to remove or correct
other hazardous conditions not covered in this chapter if the department
considers the conditions to have the potential to cause injury or illness to
any client or staff.

44:69:03:02. General
fire safety. Each birth center shall be constructed, arranged, equipped,
maintained, and operated to avoid undue danger to the lives and safety of its
occupants from fire, smoke, fumes, or resulting panic during the period of time
reasonably necessary for escape from the structure in case of fire or other
emergency. Compliance with this section does not eliminate or reduce the
necessity for other provisions for safety of persons using the structure under
normal occupancy conditions. At least two staff members shall be on duty if a
client is present. In a multilevel birth center, at least one staff member
shall be on duty on each floor containing occupied beds. Compliance with this
section does not eliminate or reduce the necessity for other provisions for
safety of persons using the structure under normal occupancy conditions.

44:69:04:01. Governing
body. Each birth center operated by limited liability partnership, a
corporation, or political subdivision shall have an organized governing body
legally responsible for the overall conduct of the birth center. If the birth
center is operated by an individual or partnership, the individual or
partnership shall carry out the functions in this article pertaining to the
governing body. The governing body shall establish and maintain administration
policies, procedures, or bylaws governing the operation of the birth center.
The governing body shall review and approve the credentials of physicians and
certified nurse midwives permitted to attend births. There shall be a system
established to reevaluate credentials every two years.

44:69:04:02. Administrator.
The governing body shall designate a qualified administrator to represent the
owner or governing body and to be responsible for the daily overall management
of the birth center. The governing body shall notify the department in writing
of any change of administrator.

44:69:04:03. Personnel.
The birth center shall have a sufficient number of qualified personnel to
provide effective and safe care. Staff members on duty shall be awake at all
times. Any supervisor shall be 18 years of age or older. Written job descriptions
and personnel policies and procedures shall be made available to personnel of
all departments and services. The birth center shall not knowingly employ any
person with a conviction for abusing another person. The birth center shall
establish and follow policies regarding special duty or staff members on
contract.

Any staff and any consultant or
volunteer providing services under the auspices of the birth center who is
required by state law to be licensed, registered, or certified shall have a
valid license, registration, or certificate. A copy of the license,
registration, or certificate shall be on file with the birth center. At least
one staff member on duty during active labor shall be certified in adult and
neonatal CPR.

44:69:04:04. Personnel
training. A birth center with three or more beds shall have a formal
orientation program and an ongoing education program for all personnel. Ongoing
education programs shall cover the required subjects annually. These programs
shall include the following subjects:

44:69:04:05. Personnel
policies and procedures. A birth center with three or more beds shall have
written policies and procedures that include the following:

(1) Operational practices
that define the services of the birth center;

(2) Written job descriptions
for each position in the birth center including the title, authority, specific
responsibilities, and minimum qualifications. Each employee shall be provided a
copy of his or her job description;

(3) All staff shall be
informed of, and have access to, the written policies; and

(4) Personnel records shall
be maintained for each person employed in the birth center that include:

44:69:04:06. Employee
health program. The birth center shall have an employee health program for
the protection of the clients. All personnel shall be evaluated by an
appropriate licensed health professional for freedom from reportable
communicable disease which poses a threat to others before assignment to duties
or within 14 days after employment including an assessment of previous
vaccinations and tuberculin skin tests. The birth center may not allow anyone
with a communicable disease, during the period of communicability, to work in a
capacity that would allow spread of the disease. Personnel absent from duty
because of a reportable communicable disease that may endanger the health of
clients and fellow employees may not return to duty until they are determined
by a physician or the physician's designee to no long have the disease in a
communicable state.

44:69:04:07. Admissions
to birth center. The governing body or owner of the birth center shall
establish and maintain admission, transfer, and discharge policies, with
written evidence to assure the clients admitted to and retained in the birth
center are within the licensure classification of the birth center. The birth
center may admit and retain, on the orders of a physician or certified nurse
midwife, only those clients for whom it can provide care safely and
effectively. Before admission of a client, the physician or certified nurse
midwife shall complete and document an assessment of a potential client prior
to accepting the client for admission and shall only admit a client that has
been assessed to have a low-risk pregnancy in accordance with § 44:69:05:05.
A birth center client shall be continually assessed to identify if her
condition deviates from a low-risk pregnancy at any time during the pregnancy,
delivery, or postpartum period. The birth center shall refer or transfer the
client to a physician or hospital when the client's pregnancy deviates from the
status of low-risk pregnancy.

The birth center practitioner shall
document information regarding current medical findings, admitting diagnoses,
and written orders for the immediate care of the client.

The client's history and physical
examination shall be completed upon admission or no more than 24 hours after
admission; or within thirty days prior to admission with documentation of an
update of the client's current medical status completed upon admission. The
client's history and physical examination shall be completed prior to delivery
except in emergency situations, a client's transfer, and the client's
discharge. A history and physical examination of the newborn infant shall be
completed upon birth and prior to discharge.

44:69:05:01. Practitioner
services. Each birth center shall have an organized practitioner service.
At least one physician, certified nurse midwife, or registered nurse shall be
on duty in the birth center at all times if a client is in active labor. Each
licensed practical nurse and other nursing personnel involved in client care
shall be under the direct supervision of a physician, certified nurse midwife,
or registered nurse.

44:69:05:02. Emergency
care. Each birth center shall establish and implement policies and
procedures for emergency care and arrange for transport to a licensed hospital
sufficiently close to provide prompt care to the birth center's clients if
needed.

44:69:05:03. Emergency
equipment and procedures to provide emergency care. Each birth center shall
have in effect a transfer protocol with one or more hospitals sufficiently
close to provide prompt inpatient hospital care to the center's clients if
needed. The protocol shall provide for an interchange of medical and other
information necessary or useful in the care and treatment of individuals
transferred between the facilities.

Each birth center shall have:

(1) Readily accessible
emergency carts or trays for the mother and newborn equipped to carry out the
written emergency procedure of the center and securely placed with a written
log of routine maintenance for readiness;

(2) Properly maintained
equipment and supplies for routine and emergency care of women and newborn
including:

44:69:05:04. Clinical
policies and procedures. Each birth center shall establish and maintain
policies and procedures, and practices to govern care, and related medical or
other services necessary to meet the client's needs. The nursing service of the
birth center shall provide safe and effective care through ongoing assessment
and monitoring for each client and newborn, including medical, physical,
mental, and emotional needs. The birth center shall establish and implement
procedures for assessment and management of symptoms including pain. The
policies shall include the following:

(a) Low-risk maternal
clients who shall be eligible for birth services offered by the birth center;

(b) Persons who shall
be ineligible for birth services at the birth center;

(2) Written plans and
procedures for consultation, backup services, transfer and transport of a
newborn or maternal client to a hospital where appropriate care is available;

(3) Policies and procedures
developed for routine and for emergency care of both the maternal and the fetus
or newborn client until completion of care by the birth center either through
completion of the care program or through transfer to other levels of care;

(4) Written evidence of the
availability of emergency transport services for clients;

(5) Staffing competency
criteria;

(6) Provision for the
education, orientation and training of clients, family and support persons in
pregnancy, childbirth, and newborn care;

(7) Procedures for the
registration of births and the examination for and the reporting of congenital
physical and mental impairments in infants;

(8) Prophylactic treatment of
the eyes of the newborn as required by SDCL chapter 34-24;

44:69:05:05. Client
plans and programs. The practitioner service of a birth center shall
provide safe and effective care from the day of admission through the ongoing
development and implementation of written plans for each client and newborn.
The client plan shall address medical, physical, mental, and emotional needs of
the client and infant.

The client plan for birth center
clients shall be based on the nursing admission assessment and approved by the
client's attending physician or certified nurse midwife. The client plan shall
describe the services necessary to meet the client's medical, physical, mental
or cognitive, nursing, and psychosocial needs and shall contain objectives and
timetables to attain and maintain the highest level of functioning of the
client. The client plan shall be completed upon admission and the birth of the
infant.

44:69:05:06. Medical
records. The birth center shall maintain a separate medical record for each
client and newborn in accordance with acceptable professional standards for the
purpose of continuity and evaluation of care, and preservation as a legal document.

44:69:06:01. Medical
orders in birth centers. For each birth center with three or more beds, all
medical orders shall be in writing and signed by a physician or certified nurse
midwife. Telephone orders may be taken only when there is an urgent need to initiate
or change a medical order. The physician or certified nurse midwife shall
authenticate all verbal and telephone order with a date, time, and signature on
the next visit to the birth center. Each client's physician or certified nurse
midwife is responsible for documenting electronic or written orders and
progress notes on each client's medical record.

44:69:07:01. Pharmaceutical
services. The requirements for pharmaceutical services in birth centers
include the following:

(1) There shall be written
orders signed by a practitioner legally authorized to prescribe for all drugs
administered to mother and infant within the birth center;

(2) There shall be policies
and procedures addressing the receiving, transcribing, issuance, storage,
control, accountability, administration, and disposal of medications or drugs
in each birth center;

(3) Each birth center shall
keep a list of the following in the drug storage area for reference:

(a) Generic and trade
names for drugs substituted within the birth center;

(b) Drugs with unique
requirements for administration used within the birth center, including enteric
coatings, sublingual, buccal, and sustained release dosage forms; and

(c) Drugs controlled
under SDCL chapter 34-20B that are used within the birth center;

(4) Written policies shall
be established addressing the type and intended use of any drug to be used by
clients within the birth center;

(5) Drugs, medications,
biologicals, and chemicals kept in the birth center shall be labeled with the
drug name, strength, and expiration date;

(6) Drug cabinets shall be
accessible only to the nurse in charge, the practitioner, or the pharmacist.
All drugs controlled pursuant to SDCL chapter 34-20B shall be kept in a securely locked box, accessible only to the nurse in charge, the practitioner, or the pharmacist;

(7) Each birth center
having narcotics shall maintain a narcotic administration record so the
disposition of any particular controlled substance can be readily traced. The
date, time administered, name of administering practitioner or nurse, the name
and strength of the narcotic, the name of the client, and the balance remaining
shall be documented in the record;

(8) Drugs may not be stored
in a refrigerator used for food storage for clients, families, and employees;

(9) Anesthetic agents and
techniques to be used in any birth center shall be determined by its governing
board;

(10) General and conduction
anesthesia may not be administered at the birth center. Local anesthesia for
pudendal block and episiotomy repair may be performed if procedures are
outlined by the clinical staff. Systemic analgesia may be administered but pain
control should depend primarily on close emotional support and adequate
preparation for the birth experience;

(11) Drugs shall be
administered only by personnel or staff licensed to administer drugs;

(12) The birth center shall
be in conformance with any applicable federal, state, and local laws and
regulations relating to drug and to controlled substances;

(13) A physician,
pharmacist, or certified nurse midwife shall be responsible for the supervision
of drug stocks in the birth center; and